Methods and compositions for diagnosis and prognosis of renal injury and renal failure

Abstract

Disclosed are methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, disclosed are assays that detect one or more markers selected from the group consisting of Prostatic acid phosphatase, Lactotransfenin, Soluble erythropoietin receptor, Von Willebrand factor, Soluble endothelial protein C receptor, and Beta-2-glycoprotein 1 as diagnostic and prognostic biomarkers in renal injuries.

We claim:  
     
       1. A method for evaluating renal status in a subject, comprising:
 performing one or more assays configured to detect a kidney injury marker selected from the group consisting of Prostatic acid phosphatase, Lactotransferrin, Soluble erythropoietin receptor, Von Willebrand factor, and Soluble endothelial protein C receptor on a body fluid sample obtained from the subject by introducing a body fluid sample obtained from the subject into an assay instrument which, for each kidney injury marker being assayed, (i) contacts all or a portion of the body fluid sample with a binding reagent which specifically binds for detection the kidney injury marker being assayed and (ii) generates an assay result indicative of binding of the kidney injury marker being assayed to the binding reagent to provide one or more assay results; 
 correlating the assay result(s) generated by the assay instrument to a likelihood that the subject is at risk of a future acute renal injury within 72 hours of the time at which the body fluid sample is obtained from the subject by using the assay result to assign the subject to a predetermined subpopulation of individuals having a known predisposition of a future acute renal injury within 72 hours; and 
 treating the subject based on the predetermined subpopulation of individuals to which the patient is assigned, wherein the treatment comprises one or more of initiating renal replacement therapy, withdrawing delivery of compounds that are known to be damaging to the kidney, delaying or avoiding procedures that are known to be damaging to the kidney, and modifying diuretic administration. 
 
     
     
       2. A method according to  claim 1 , wherein said risk of a future acute renal injury is a risk of future acute renal failure (ARF). 
     
     
       3. A method according to  claim 2 , wherein said assay result(s) comprise one or more of:
 (i) a measured concentration of Prostatic acid phosphatase, 
 (ii) a measured concentration of Lactotransferrin, 
 (iii) a measured concentration of Soluble erythropoietin receptor, 
 (iv) a measured concentration of Von Willebrand factor, and 
 (v) a measured concentration of Soluble endothelial protein C receptor. 
 
     
     
       4. A method according to  claim 1 , wherein the subject is selected for evaluation of renal status based on the pre-existence in the subject of one or more known risk factors for prerenal, intrinsic renal, or postrenal ARF. 
     
     
       5. A method according to  claim 1 , wherein the subject is selected for evaluation of renal status based on an existing diagnosis of one or more of congestive heart failure, preeclampsia, eclampsia, diabetes mellitus, hypertension, coronary artery disease, proteinuria, renal insufficiency, glomerular filtration below the normal range, cirrhosis, serum creatinine above the normal range, sepsis, injury to renal function, reduced renal function, or ARF, or based on undergoing or having undergone major vascular surgery, coronary artery bypass, or other cardiac surgery, or based on exposure to NSAIDs, cyclosporines, tacrolimus, aminoglycosides, foscarnet, ethylene glycol, hemoglobin, myoglobin, ifosfamide, heavy metals, methotrexate, radiopaque contrast agents, or strep tozotocin. 
     
     
       6. A method according to  claim 1 , wherein said risk of a future acute renal injury is a risk within 48 hours of the time at which the body fluid sample is obtained. 
     
     
       7. A method according to  claim 1 , wherein said risk of a future acute renal injury is a risk within 24 hours of the time at which the body fluid sample is obtained.